The purpose of this FOA is to provide support for the
development of broadly interdisciplinary training programs in global health
directed towards encouraging innovation in products, processes, and policies.
Trainees should be at the postdoctoral level or have attained a terminal
degree in their fields. Training projects should identify critical health
needs in Low and Middle Income Countries (LMICs) that can be addressed
through Innovation, and carry out the scientific research necessary to
develop, validate, and test their concepts. To increase the translation of
research findings into realized health benefits, project design should
include considerations of implementation appropriate to low resource settings
in LMICs, particularly regarding increased effectiveness, affordability,
accessibility, ease of use or delivery, and/or scalability. This FOA
emphasizes hands-on, problem-solving, and collaborative approaches and allows
U.S. and LMIC trainees to be trained together. By engaging multiple entities
within and among institutions, the proposed programs should also build
institutional capacity for interdisciplinary training in global health,
stimulate new collaborations, and increase the pipeline of researchers from a
wide variety of fields who engage in global health research.

Key Dates

Posted Date

October 14, 2011

Open Date (Earliest Submission Date)

November 16, 2011

Letter of Intent Due Date

November 16, 2011, November 15, 2012

Application Due Date(s)

December 15, 2011, December 14, 2012, by 5:00 PM local time
of applicant organization.

The
Framework Programs for Global Health Innovation (FRAME Innovation) will provide
support to institutions in the U.S. and in Low and Middle Income Countries
(LMICs) to build capacity within their institutions to develop broadly
interdisciplinary training programs in global health directed towards
encouraging Innovation in health-related products, processes, and policies.
Trainees should be at the postdoctoral level or have attained a terminal degree
in their fields. Training should be directed towards identifying critical
health needs in LMICs that can be addressed through Innovation, and trainees
should carry out the scientific research necessary to develop, validate, and
test their concepts. To increase the translation of research findings into
realized health benefits, project design should include considerations of
implementation appropriate to low resource settings in LMICs, particularly regarding
increased effectiveness, affordability, accessibility, ease of use or delivery,
and/or scalability. This FOA emphasizes hands-on, problem-solving, and
collaborative approaches and allows U.S. and LMIC trainees to be trained
together in joint programs. By engaging multiple entities within and among
institutions, the proposed programs should also create the institutional
infrastructure necessary to support interdisciplinary training in global health
Innovation, stimulate new collaborations, and increase the pipeline of
researchers from a wide variety of fields who engage in global health
research. This FOA is consistent with the goals of the Fogarty International
Center (FIC) Strategic Plan (http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx)
to support and facilitate global health research in both communicable and
non-communicable diseases, build partnerships between health research
institutions in the U.S. and abroad, and train the next generation of
scientists to address global health needs.

Background
and Rationale

It is important that investigators from a wide variety of
fields are engaged in global health research as addressing the most urgent global
health challenges will require diverse expertise. This is true, in part,
because of the public health nature of these challenges, which are embedded in
the complex relationships among biological, social, economic, political, and
environmental determinants. However, there is also a growing literature that describes
how some of the most transformative advances in Science and Technology have
come from the intersection of disciplines, with collaborators working together,
challenging and complementing each other’s assumptions and methodologies, and together
discovering novel solutions. A recent report from the National Research
Council’s Board on Life Sciences has suggested that greater integration within
biology and in collaboration with physical and computational scientists and
engineers will be necessary to create a New Biology for the 21st Century (http://www.nap.edu/openbook.php?record_id=12764&page=1).
Indeed, collaborative research across these disciplines fueled the development
of such fields as genomics, nanobiology, bioinformatics, and systems biology
and is producing cutting edge advances in every field of health-related
research, from cancer to immunology, brain disorders, blindness, and infectious
diseases (http://web.mit.edu/dc/policy.html).
While basic biomedical research has forged ahead with this paradigm, in many
academic institutions worldwide there are often little awareness and few
opportunities for investigators outside the Schools of Public Health and
Medicine to participate in global health research or for trainees in any field
to engage in interdisciplinary research. To address disease in the context of
international public health, in addition to the physical sciences and
engineering, fields including the social sciences, law, business, communications,
veterinary sciences, agriculture, environmental sciences, and others are also
likely to play critical roles.

At the same time, there is a recognized gap in the ability
to translate biomedical and behavioral research findings into implementable
applications, both from the bench to the clinic and to public health.
Businesses have long used an innovation model to accelerate this translation,
by considering the constraints and requirements for implementation and the
needs of the target communities from the outset of the development process. An
integrated process that considers implementation of research outcomes at an
early stage in the research design process might similarly begin to close the
translational gap in global health research.

There are an increasing number of opportunities from the
U.S. government and other funders to compete for innovation research grants and
innovation challenges. However, few universities have systematically explored
the concept of innovation or have created mechanisms to prepare students and
faculty to respond to these opportunities. This FOA addresses these gaps.

This is the third in a series of initiatives from FIC
focused on building institutional capacity in broadly multidisciplinary global
health education, research, and research training on campuses in the US and
LMICS. The Framework Programs for Global Health (FRAME) supported the
development of multidisciplinary global health curricula, associated research
experiences, and the formation of coordinating administrative entities. FRAME
Signature Innovations Initiative (FRAME-Sig), a one year program supported by
funds from the American Recovery & Reinvestment Act of 2009, moved that
paradigm from education to research practice by supporting the development of
pilot programs in interdisciplinary research training in global health
innovation. The current solicitation is based on an expansion of this pilot
program. For a list of current FRAME-Sig awards, see

Working Definition of Innovation: While many definitions of
“innovation” are acceptable, we suggest as a working definition an
implementation that is often disruptive of the prevailing product, process,
policy, or paradigm and creates an outcome that is more effective, affordable,
accessible, easier to use or deliver, and/or provides superior scalability. A
classic example is the replacement of the main-frame computer by the PC, a
product developed at the intersection of materials engineering, computer science,
and business innovation. Rather than a huge, expensive machine housed in a
temperature controlled room that required an expert to run, a PC (and later
laptops and tablets) were affordable by individuals, could go almost anywhere,
and could be used by a child of five. While not as powerful as the mainframe,
it was good enough for the average individual’s needs and was widely adopted.
The industry then turned its attention to increasing the power of the PC. Once
in the hands of the individual, the uses to which it has been put, especially
in concert with the open innovation platform provided by the internet and the
worldwide web, were not imagined by its originators. The cell phone is
similarly becoming an innovation platform all over the world. Both of these
tools have found increasing applications to managing health and health
systems. A similar paradigm can easily be imagined for the development, use,
and/or delivery of needed drugs, vaccines, diagnostics, and medical devices for
inaccessible and low-resource areas, and for interventions that affect health
behavior, information flow and analysis, and policy.

Innovations for low resource settings: There are an
increasing number of innovations under development that are relevant to low
resource settings and originated with an interdisciplinary approach. These
include new point of care diagnostics, such as the adaptation of lab-on-a-chip
technologies and telemedicine facilitated through cell phones, which will allow
faster, less expensive and more accurate diagnosis in field settings lacking
expert personnel and refrigeration; sophisticated function but low cost
prosthetics that can be locally manufactured for dollars (versus thousands of
dollars) in the countries in which they are used; low-cost incubators for
premature babies using materials sourced locally so that replacement parts are
readily available; genetically engineered plants for the delivery of vaccines;
use of rodents as sensors to detect landmines or TB in sputum samples;
combinations of technology, monitoring, and behavioral incentives to encourage
patient medication adherence to increase the likelihood that an entire course
of medication is completed; intensive agricultural training to increase the
nutritional status of HIV-affected families and communities and improve health
outcomes for patients on anti-retroviral drugs; use of information technology
to improve health care delivery, access to education, or access to clean water
as these impact health; and many other examples.

Innovation and Innovative: It should be noted that “innovation”
and “innovative” are not equivalent. While innovations are often innovative,
in the sense of novel, and may indeed break with existing paradigms in the
field, an approach may be novel but ineffective. An innovation implies a
successful implementation and, indeed, may take a known product or process and modify
it or adapt it to a new use, with greatly improved outcomes.

Interdisciplinary: The term “interdisciplinary” is used to
imply an active interaction and contribution of trainees and mentors from
different fields of study and not merely the participation of individuals with
different expertise at different stages of a process. A team approach is one
way to achieve this, with the entire team contributing from conception of the
project through research and implementation. Whatever model is chosen, the
purpose of the training program should be to stimulate trainees to look at a
problem with unbiased eyes and find the best solution by drawing on the
collective insight, expertise, and disparate methodologies of the participants.

Objectives

Specifically, the objectives of this FOA are:

1. To expand the base of expertise needed and available to
tackle the challenging problems of global health by developing
trans-institutional, problem-solving based research training programs that will
bring together trainees of widely diverse expertise to work together on
research problems in Global Health. Trainees should be postdoctoral scientists,
or researchers who have obtained a terminal professional degree in their
fields, and may include within one program or interdisciplinary project team individuals
from both the U.S. and LMICs.

2. To stimulate new knowledge, approaches, and solutions in global
health, in part by exploring the question: What is an "innovation"
in the context of global health and how might an institution create an enabling
environment to encourage innovations in products, processes, or policy to
emerge out of their research and research training activities? Training
projects should identify critical health needs in LMICs that can be addressed
through Innovation, and carry out the scientific research to validate the
concept and test its effectiveness. Research projects should be directed
towards producing specific global health research "products" that
have the potential for effective implementation and are likely to contribute to
improved health outcomes. These may include technological, informatics,
biomedical, modeling, or other products; prevention, adherence, or other
intervention strategies; as well as policy, business, educational, or other
deliverables that are appropriate to the infrastructure and social context in
which they will be used. Not all research problems are best served by this
type of approach; consequently the problems chosen and the way they are
conceptualized and framed will be critical to the success of the research
training projects and the sustainability of the program. Similarly, understanding
and anticipating the challenges of implementation from the outset of a research
project may help determine which among many possible approaches are chosen to increase
the probability that research is quickly translated into real health benefits.

3. To integrate global health research communities within
and among institutions by building capacity at the institution(s) to support an
interdisciplinary research training program in Global Health Innovation. This
may involve raising awareness of global health issues and the goals of the
program throughout the institution; developing shared research training
resources and activities; developing electronic or other platforms to encourage
participation across many disciplines and to assemble teams (a “virtual
marketplace”); creating a space to interact (a physical incubator or a virtual
lab); developing an agreed-on concept of innovation and creating an enabling
environment to encourage innovation in global health research; developing a
course in innovation; developing mentoring and training models to ensure that teams
operate effectively and have appropriate oversight; assembling an Advisory
Board to provide feedback and guidance; and by many other means. In some
institutions, interdisciplinary centers that already exist but carry out
research that does not consider the constraints of low resource health systems,
may be powerful platforms for adapting research goals towards the needs of a
low-resource population. Similarly, institutions that have built Global Health
Centers, either through previous Framework Program support or through other
funding, may build on that administrative structure to develop this
trans-institutional training application.

Scope

The proposed activities may encompass the many research
fields in global health broadly or may be more focused, thematically or
geographically, but should address the health concerns of populations living in
low resource settings in LMICs. The applicant may propose completely new
activities or build significantly on existing activities that will take these
initiatives to a new level or result in a new use of available resources. The
applicant should not propose to merely sustain an initiative already in place.

The specific hands-on training projects may take many
forms. For example, a research team might undertake to design a product or
intervention that addresses a specific health need, taking into consideration
(as applicable) issues of access, infrastructure, barriers to adoption,
affordability, scalability, regulatory and legal environment, sourcing of
materials, data management, disposal and recycling, environmental impact and
energy efficiency, technology transfer, evaluation of effectiveness, and
business model, where such considerations of implementation may significantly
impact initial research design.

Participants and Consortia

The application must include participation by at least three
Schools, departments, or entities of distinct disciplines, either at the
applicant institution or among a consortium. Subspecialties within a field,
such as Medicine, would not qualify as distinct disciplines, and three
departments within one School are unlikely to meet this standard.

Applicants may choose to form consortia that include other
academic or research institutions outside the university that could provide
synergistic or special expertise and experience, or that share common goals.
These may include institutions in the applicant country or foreign
institutions, and may also include partners from other sectors (private,
governmental, and non-governmental organizations) as needed for the program. These
may or may not involve formal subcontracts. For US institutions, the
development of innovations to be used within a LMIC will require working
closely with scientists and other professionals in those countries and having
trainees embedded within the context of the research problems to be addressed.
Consequently, U.S. applicants are required to collaborate with named institutions
or research entities in LMICS, such that all participating institutions realize
benefits from the interdisciplinary training program, including the opportunity
to nominate postdoctoral fellows to participate in the training projects. LMIC
institutions, where appropriate, may wish to take advantage of advanced
expertise that might complement and enhance the strengths of their own
institutions by partnering with other institutions either locally or internationally.
While applicants may include partners from non-U.S. high income countries,
their expected roles would be as mentors or consultants. Trainees must be
citizens of the U.S. or an LMIC.

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH
appropriations, and the submission of a sufficient number of meritorious
applications.

Award Budget

Applicants may request up to $350,000 total costs per year.

Award Project Period

The scope of the proposed project should determine the
project period. The maximum period is 5 years.

Other Award Budget Information

Stipends, Tuition, and Fees

D43 awards provide stipends as a subsistence allowance to
help defray living expenses during the research training experiences.

Where appropriate, NIH will contribute to the combined cost of tuition and
fees at the rate in place at the time of award, where required for selected
courses or for full-time enrollment

Trainees should be paid a stipend commensurate with their professional
experience and the usual rates at their institutions. Applicants should use
an appropriate stipend level and can use the NRSA levels as guidance (see Ruth L. Kirschstein
National Research Service Award (NRSA) site) or use grantee institutional
policies for comparable trainees at the training institution.

Trainee Travel

Trainee travel for the purpose of carrying out research is
allowable. In addition, trainee travel to attend scientific meetings and
workshops or to obtain specialized training necessary for the individual’s
research training experience is an allowable trainee expense.

Training Related Expenses

NIH will provide funds
to help defray other research training expenses, such as health
insurance, staff salaries, consultant costs, equipment, research supplies,
and faculty/staff travel directly related to the research training
program. Trainee research expenses for individuals or teams are allowable and
should be justified in the budget justification. In addition, applicants may
request funds to support the development of resources or activities necessary
to develop institutional capacity for an interdisciplinary training program.
Applicants should include travel expenses for the PD/PI(s) to participate in
an annual network meeting at NIH of all grantees supported as a result of
this funding opportunity.

Indirect Costs

Indirect Costs (also known as Facilities &
Administrative [F&A] Costs) are reimbursed at 8% of modified total direct
costs (exclusive of tuition and fees and expenditures for equipment), rather
than on the basis of a negotiated rate agreement.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section
III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher
Education Institutions are always encouraged to apply for NIH support as Public
or Private Institutions of Higher Education:

All Program Director(s)/Principal
Investigator(s) (PD(/)PI(s)) must also work with their institutional officials
to register with the eRA Commons or ensure their existing eRA Commons account
is affiliated with the eRA Commons account of the applicant organization. NOT-OD-11-090:

The sponsoring institution must assure support for the proposed program.
Appropriate institutional commitment to the program includes the provision of
adequate staff, facilities, and educational resources that can contribute to
the planned program.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Non-domestic entities are restricted to institutions in
"low- and middle-income" countries as defined by the World Bank
according to Gross National Income per capita as “low-income,”
“lower-middle-income,” and “upper-middle-income”; see: http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLSb).
See also "Additional Information on Eligibility”, Section III.3 below.

Required Registrations

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

The PD(s)/PI(s) should be an established investigator in the scientific area in
which the application is targeted and capable of providing both administrative
and scientific leadership to the development and implementation of the proposed
program. The PD(s)/PI(s) will be expected to monitor and assess the program and
submit all documents and reports as required.

Only one application per institution (normally identified by
having a unique DUNS number or NIH IPF number) is allowed. However, institutions may participate in
more than one consortium, and may be both an applicant institution and a
participating consortium partner.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission
Applications from the SF 424 (R&R) Application Guide.

Requirement
for Interdisciplinary Participation: Participation by a minimum
of three Schools, departments, or other entities representing distinct
disciplines is required. Subspecialties within a field, such as Medicine,
would not qualify as distinct disciplines. For consortia, the three disciplines
may be distributed among the partner academic or research institutions. If
there is any question about whether disciplines are distinct, please contact
the FIC Scientific Contact (Section VII.1).

Pre-requisite
activities in Global Health: Institutions or consortia are
eligible to apply if they participate, as a recipient or significant
collaborator, on a minimum of five research or research training grants or
research contracts in global health topics involving significant participation
by investigators in LMICs (as defined by the World Bank, above), such as a role
as Program Director(s)/ Principal Investigator(s) (PD(s)/PI(s)) or key
personnel or as a listed performance site. All of these awards should be from
funding sources external to the institution and should be active on the
application receipt date for this FOA, with at least two of these awards from
the NIH. NIH R03 awards, however, do not count as qualifying grants. . If a
consortium of institutions applies as partners, the institutions applying may together
meet this pre-requisite (i.e. as the sum of all the partners). These
pre-requisite grants are not intended to act as "parent grants" for
the training program, as the training models proposed will likely not fit
easily within established research programs. Indeed, in some cases this might
un-necessarily restrict the possibilities of the research questions asked and
the training models explored. Rather they provide a metric of the expertise
available in global health research at the institution and the ability of the
entire consortium community to engage and provide mentorship for trainees. They
may also provide a necessary network of international collaborations for
training projects. Include a Table in the Research Training Program Plan that
lists the qualifying grants and contracts, as detailed below under Section IV.2.
If there are questions about qualifying grants or an institution’s eligibility,
please contact the FIC Scientific Contact (Section VII.1

Institutional
Commitment: Applications should include letters from the
appropriate head research administrator at all participating institutions confirming
the institutions' commitment to the proposed research training program. The
institution(s) should state their commitment to overcoming any administrative
obstacles to the implementation of the application, such as accommodation for participation
by multiple Schools at the university or collaboration with other institutions.
Appropriate institutional commitment to the program also includes the provision
of adequate staff, facilities, and resources that can contribute to the planned
program.

Mentors

Researchers from diverse backgrounds, including racial and
ethnic minorities, persons with disabilities, and women are encouraged to
participate as mentors. Mentors should have research expertise and experience
relevant to the proposed program. Mentors must be committed to continue their
involvement throughout the total period of the mentee’s participation in this
award.

Trainees

Trainees must be citizens of either the U.S. or of an LMIC.

In the fields in which it is appropriate, postdoctoral
trainees must have received, as of the beginning date of their appointments, a
PhD, MD, DDS, or comparable doctoral degree from an accredited domestic or
foreign institution. Eligible doctoral degrees include, but are not limited to,
the following: DMD, DC, DO, DVM, OD, DPM, ScD, EngD, Dr
PH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD as well
as a doctoral degree in nursing research. Since this is a broadly
interdisciplinary program, however, trainees that have attained the usual terminal
degree in their fields, which in many fields does not include a doctorate, are
acceptable trainees for the program.

Short term training is allowed as an adjunct to the training
program and will usually take the form of courses or workshops. These should be
targeted towards post-terminal degree students but may include other members of
the research community, including students and faculty, who might also benefit
from focused and topical training in global health innovation and related
material.

Training Program

A research training grant must be used to support a program
of full-time research training. Within the full-time training period, research
trainees who are also training as clinicians must devote their time to the
proposed research training and must confine clinical duties to those that are
an integral part of the research training experience. The program may not be
used to support studies leading to the MD, DDS, or other clinical,
health-professional training.

Section
IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow the instructions in the SF 424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 (R&R)
Application Guide and the Table of
Page Limits must be followed.

SF424 (R&R) Other Project Information Component

Follow all instructions provided in the SF424 (R&R)
Application Guide for Preparing Institutional Ruth L. Kirschstein National
Research Service Award (NRSA) with the following modifications:

Project Summary /Abstract

Provide an abstract of the entire application,
including the long-term goals and objectives of the program, key elements of
the research training plan, and brief descriptions of planned research training
program. Include the rationale and design of the program, the plannedduration
and projected number of trainees, including their levels (i.e., predoctoral,
postdoctoral, faculty).

Advisory Committee (Uploaded via the Other Attachments
section)

A plan must be provided for the appointment of an Advisory
Committee to monitor progress. Composition, responsibilities, frequency of
meetings, and other relevant information should be included. Describe the
composition of the Advisory Committee, identifying the role and the desired
expertise of members. Describe how the Advisory Committee will function in
providing oversight of the development, implementation, and evaluation of recruitment
strategies, the recruitment and retention of candidates, and the evaluation of
the overall effectiveness of the program. Note that Advisory Committee members should
not be named in the application, particularly if they include individuals from
outside the institution(s). Please name your file “Advisory_Committee.pdf”

The
filename provided for each “Other Attachment” will be the name used for the
bookmark in the electronic application in eRA Commons.

Training and Research & Related (R&R) Budget Component

Follow all instructions provided in the SF424 (R&R)
Application Guide with the following modifications:

Both the Training Budget Component and the R&R Budget
Component are required for a complete application.

Include all personnel other than the Training PD(s)/PI(s)
in the Other Personnel section, including clerical and administrative staff.

Use the section on Participant/Trainee Support Costs to include
all allowable categories of funds requested to support participants in the
program.

PHS 398 Research Training Program Plan

All Supplemental Instructions to the SF424 (R&R) for
Preparing Institutional Ruth L. Kirschstein National Research Service Award
(NRSA) Application must be followed, with the additional instructions described
below:

Omit NRSA Tables 1-12 with the following
exceptions: include Tables 2; 5B (but do not indicate NRSA-training grant
eligible trainees); and 6Bnew (list representative publications, no abstracts,
for each mentor for any previous or current postdoctoral fellow, but omit the
training grant eligible trainee, TGE, or PMCID designations. You should omit
the corresponding requested text in the training plan for all other Tables..

Program Administration (Component of Program Plan)

Describe the acknowledged strengths, leadership and
administrative skills, and scientific expertise of the Training PD(s)/PI(s).
Include active research and the planned strategy and administrative structure to
be used to oversee and monitor the program. For applications with multiple PD(s)/PI(s),
address the Leadership Plan and how the combined knowledge, skills and
experience of the individual PD(s)/PI(s) will enhance the likelihood of success
of the program. .

Program Faculty (Component of Program Plan)

Describe in general terms the complementary expertise
and experiences of the proposed mentors. Provide an overview of their active
research and other scholarly activities, as well as track records of mentoring
and training.

Proposed Training (Component
of Program Plan)

Provide an overview of the proposed program: Describe
the immediate and long-term objectives of the program, including training or career
development activities that will be used to ensure that the objectives of the
program are met. Include information about planned courses, curricula,
seminars, workshops, or tutorials that will be incorporated into the training program
and mentored research experiences and activities. Institutions with existing training
or career development programs must explain what distinguishes this application
from the others, how the programs will synergize, if applicable, and make it
clear that the faculty, potential trainees, and resources are robust enough to
support additional programs. The description should include planned strategies
to be used to ensure that the objectives are met. The Training PD(s)/PI(s)
should also describe past research career development activities/experiences
including those of mentors, documenting the success of former scholars in establishing
independent productive scientific careers. Programs should provide all trainees
with additional professional development skills and career guidance including
instruction and training in grant writing in order to apply successfully for
future career development and independent research support. All postdoctoral
trainees should also be provided with instruction in laboratory and project
management.

Program Evaluation (Component of Program Plan)

Describe an evaluation plan to review and determine
the effectiveness of the program. This should include plans to obtain feedback
from current and former scholars to help identify weaknesses and to provide
suggestions for program improvements, as well as plans for assessing scholars’
career development and progression, including metrics such as degree completion
(if applicable), publications, and subsequent positions. Specified evaluation
metrics should be tied to the goals of the program. Evaluation results should
be included in future competing continuation (renewal) applications and as part
of the Final Progress Report.

Trainee Candidates (Component of Program Plan)

Describe in general terms the pool of potential
candidates including information about the types of prior clinical and research
training and career level required for the program. Do not name prospective Trainees.
Describe plans to recruit candidates and explain how these plans will be implemented
(see also section on Recruitment and Retention Plan to Enhance Diversity). Describe
the criteria to be used for candidate evaluation in the selection of Trainees. Provide
brief summaries of training plans that the program will employ. The application
should contain a description of how training plans will be tailored to the needs
of the prospective candidates, taking into account their past experiences and
competences.

Institutional Environment and Commitment to the Program
(Component of Program Plan)

The application must include a statement from the
applicant institution(s) describing the commitment to the planned program. The
institution must assure that essential time will be allowed for the PD(s)/PI(s),
other faculty and mentors ,

Recruitment and Retention Plan to Enhance Diversity

This section only applies to U.S.
trainees in this program: Individuals are required to comply with
the instructions for Recruitment and Retention Plan to Enhance Diversity as
provided in Chapter 8 of the SF424 (R&R) Application Guide.

Plan for Instruction in the Responsible Conduct of
Research

Individuals are required to comply with the
instructions for Plan for Instruction in the Responsible Conduct of Research as
provided in Chapter 8 of the SF424 (R&R) Application Guide.

Other
considerations for this FOA:

The purpose of this FOA is to create opportunities and
resources for interdisciplinary training in Global Health Innovation. We
expect entities within the university to work together, and some applicants may
put together consortia of institutions to jointly develop training plans. As
such, within the research training program plan, applicants should also address
the following:

1. Describe how faculty from different Schools or other
components within the institution(s) will communicate and coordinate their
efforts on this program to develop the training program and to provide
effective mentoring. All key faculty who will be involved in mentoring should
include biosketches.

2. Describe how trainees will interact with each other and
how they will be mentored to achieve the goals of the interdisciplinary
training projects. U.S. and LMIC students may be trained together in joint
teams and this is strongly encouraged.

3. While it may be premature to describe in detail, provide
specific examples of the types of projects that might be undertaken within the
training program, how training projects will be developed, and the types of
"deliverables" that might emerge from the research projects.

4. For consortia, explain why the particular partnerships
were chosen, how they add value to the proposed program, why these partners
have the potential to successfully develop a program together, and how each
will benefit from the program.

5. Define “innovation” in the context of this application
(as consistent with the spirit of the definition in the Section I, above, and
as distinct from "innovative"), and describe how the activities
proposed and the partnerships assembled contribute to realizing that concept
within the training paradigm.

6. Describe how you will build capacity at the
participating institutions to support an interdisciplinary research training
program in Global Health Innovation.

7. Provide a Table describing at least five qualifying
global health grants and contracts at the institution or among the members of
the consortium including the following information: source of funding, name of
PD(s)/PI(s), institution holding the award, grant or contract number, total
amount of award, and end date. If space constraints prevent a complete list of
eligible grants within the consortium (in additional to the five required and
listed in the Table), you may choose to simply indicate the number of
additional eligible active research grants and contracts and research training
grants held at the institutions.

For training-related research projects involving human
subjects, trainees should have written documentation of education in the
protection of human subjects, comply with required federal citations, and obtain
approval from an institutional (or ethical) review board or committee at the
applicant institution and, if different, at the LMIC institution in which the
research is being conducted. Please see: Procedures for Registering
Institutional Review Boards and Filing Federal-Wide Assurances of Protection
for Human Subjects (FWAs) at http://www.hhs.gov/ohrp/assurances/assurances_index.html.

Where appropriate, the design of training-related research
projects should take into account potential sex and gender differences that may
affect the questions asked and the analyses performed. These might include
different responses to and impacts of health interventions, differences in
physiology, and different behavioral bases for disease prevention strategies.

Appendix

Do not use the appendix to
circumvent page limits. Follow all instructions for the Appendix as described
in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants are
responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of on-time
submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF 424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD(s)/PI(s) Commons ID in the credential field will
prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115,

Section V. Application Review
Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the program to exert a
sustained, powerful influence on the research field(s) involved, in consideration
of the following review criteria and additional review criteria (as applicable
for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact.

Training Program and
Environment

Have the applicants proposed a program that will
stimulate hands-on, problem solving-based training in a well-integrated and
highly interactive interdisciplinary context? Are the training activities
directed towards producing specific global health “products”, as defined in
this FOA? Do the applicants justify why the specific participating disciplines
were selected and how they will be engaged? Do the qualifying grants reflect
significant global health experience at the institution(s)?

Do the applicants take advantage of the unique scientific
environment in which the training will be done, including the availability of
global health research expertise or other interdisciplinary research
initiatives? Are the institutional support, equipment and other physical
resources available to the investigators adequate for the project proposed? Does
the program have a rigorous evaluation plan to assess the quality and
effectiveness of the training? Are appropriate letters of support from the
research leadership of the participating entities included?

Have the applicants proposed to build appropriate
infrastructure or resources to facilitate the goals of the training program and
create the institutional capacity to support such a program? Is there a clear
plan for how the mentors will interact with each other and with the trainees?
Is there a clear plan for how the trainees will interact with each other?

Does the program provide new training opportunities, new
training models, and new resources for interdisciplinary research training in
global health at the institution(s)? Will the program be transformative for
the participating partner institutions? Is it likely that the training program
will lead to new approaches to critical global health problems?

Significance and Innovation

Does the research
training program proposed address an important problem or critical barrier to
progress in the field of global health? If the aims of the program are
achieved, will scientific knowledge, technical capability, and/or clinical
practice be improved? Will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? Are the products of the training projects
likely to have a significant impact on the health of populations in
participating LMICs?

Does the application challenge and seek to shift current
research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation or technologies, or
interventions? Is a refinement, improvement, or new application of theoretical
concepts, approaches or methodologies, instrumentation, or interventions
proposed?

Does the program promote and
support “innovation” in global health research, as framed in the FOA and defined
by the applicants, through its training paradigm and the resource
infrastructure it will establish? Do all participating components and
institutions contribute to the innovation goals of the application?

Training Program Director(s)/Principal Investigator(s)
(PDs/PIs)

Does the PD(s)/PI(s) have the scientific background,
expertise, and experience to provide strong leadership, direction, management,
and administration to the proposed research training program? Does the PD(s)/PI(s)
plan to commit sufficient time to the program to ensure its success? Is
sufficient administrative and research training support provided for the
program? Do the PD(s)/PI(s) have the necessary experience in global
health-related research and training to lead an effort in this area? Do the PD(s)/PI(s)
have experience in leading a program involving multiple participating
components?

For applications designating multiple PD(s)/PIs: Is a strong justification provided that the multiple PD/PI leadership approach
will benefit the training program and the trainees? Is a strong and compelling
leadership approach evident, including the designated roles and
responsibilities, governance, and organizational structure consistent with and
justified by the aims of the training program and with the complementary
expertise of each of the PD(s)/PIs?

Preceptors/Mentors

Are there sufficient preceptors/mentors with
appropriate expertise to meet the needs of the interdisciplinary research
training program proposed? Do the preceptors/mentors have strong records as
researchers, including successful competition for research support in areas
directly related to the proposed research training program?

Trainees

Are there adequate plans to identify, recruit, and
select candidates, from all the participating disciplines, with an interest in exploring
interdisciplinary, team research and Global Health Innovation?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Recruitment & Retention Plan to Enhance Diversity

This section only applies to U.S.
trainees in this program: Peer reviewers will separately evaluate
the recruitment and retention plan to enhance diversity after the overall score
has been determined. Reviewers will examine the strategies to be used in the
recruitment and retention of individuals from underrepresented groups. The
review panel’s evaluation will be included in an administrative note in the
summary statement.

Training in the Responsible Conduct of Research

Taking into account the specific characteristics of
the training program, level of trainee experience, and the particular
circumstances of the trainees, the reviewers will address the following
questions. Does the plan satisfactorily address the format of instruction,
e.g. lectures, coursework and/or real-time discussion groups? Do plans include
a sufficiently broad selection of subject matter, such as conflict of interest,
authorship, data management, human subjects and animal use, laboratory safety?
Do the plans adequately describe how faculty will participate in the
instruction? Does the plan meet the minimum requirements
for RCR, i.e., eight contact hours of instruction every four years? Plans and past record will be rated as acceptable or unacceptable, and the
summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds
with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of
review by the the FIC Advisory Board . The following will be considered in
making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

Considerations of geographical distribution.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program. Accordingly, trainees are hereby notified that they may be contacted after the completion of this award for
periodic updates on various aspects of their employment history, publications,
support from research grants or contracts, honors and awards, professional
activities, and other information helpful in evaluating the impact of the
program.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

The Non-Competing
Continuation Grant Progress Report (PHS 2590) and financial statements as described
in the NIH
Grants Policy Statement are required annually. Continuation support
will not be provided until the required forms are submitted and accepted. Chapter
8 of the SF424 (R&R) Application Guide, Additional Instructions for
Preparing a Progress Report for an Institutional Research Training Grant,
Including Ruth L. Kirschstein National Research Service Awards, must be
followed.

Failure by the grantee institution to submit required forms
in a timely, complete, and accurate manner may result in an expenditure
disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.